Reporting Forms and Templates
As part of the reporting requirements for clinical investigations of medical devices and in vitro diagnostic medical devices by the NREC-MD, please use the appropriate templates and forms provided below.
Reporting from clinical investigations approved by local RECs under the Council Directives 93/42/EEC and 90/385/EEC (SI 252/1994 and SI 253/1994 as amended)
As of 26 May 2021, all aspects of reporting, including annual, safety and device deficiency reporting from studies previously approved by local RECs under the Council Directives 93/42/EEC and 90/385/EEC (SI 252/1994 and SI 253/1994 as amended) should be directed to the NREC-MD.
On the submission of a first such report, we ask the applicant to also submit all relevant study documentation, such as original application documents and previous annual reports. Applicants must submit an annual report to the NREC within 30 days following the anniversary of the date on which approval was given and for every year thereafter for the duration of the study. End-of-study reports should be submitted to the National Office within one year of the conclusion of the research. The submission of all such reports will be acknowledged in writing by the National Office.
The Cover Form should be submitted to the National Office with any safety reports such as annual safety reports and reports of serious adverse events or device deficiencies. It should be submitted to the National Office promptly following identification of the event/deficiency.
Annual Progress Report:
Annual Progress Reports must be submitted to the National Office on the anniversary date of final NREC approval and for every year thereafter for the duration of the study.
End of Study Report:
The End of Study Report must be submitted to the National Office within 12 months of the end of the clinical investigation/ performance study.